FDA.reportPublic FDA data

WINGMAN18

Primary DI
00856492005234
Brand
WINGMAN18
Company
REFLOW MEDICAL, INC.
Model
WGM18090US
Catalog number
WGM18090US
Device description
Wingman Crossing Catheter, 18X90cm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
PDUCatheter For Crossing Total Occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856492005234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856492005234008564920052348564920052340856492005234

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Contacts#

Phone, Email table
PhoneEmail
949.481.0399quality@reflowmedical.com

Regulatory Flags#

DUNS number
962545294
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850025525022Spex LPSLP35135US2021-06-10
00850025525039Spex LPSLP35150US2021-06-10
00850025525213SINCSINC35090US2024-02-19
00850025525220SINCSINC35135US2024-02-19
00850025525060SPEX35SPN35050US2021-09-23
00850025525077SPEX35SPN35090US2021-09-23
00850025525084SPEX35SPN35135US2021-09-23
00850025525091SPEX35SPN35150US2021-09-23
00850025525015Spex LPSLP35090US2021-06-10
00850025525046coraCrossCRX14135US2021-06-03
00850025525053coraCrossCRX14150US2021-06-03
00856492005692coraForceFRC14150US2020-12-18
00856492005708coraForceFRC14135US2020-12-18
00856492005715coraFlexFLX14135US2020-12-18
00856492005722coraFlexFLX14150US2020-12-18
00856492005630Spex LPSLP14090US2020-05-08
00856492005647Spex LPSLP14135US2020-05-08
00856492005654Spex LPSLP14150US2020-05-08
00856492005661Spex LPSLP18090US2020-05-08
00856492005678Spex LPSLP18135US2020-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008165ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008172ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008189ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008196ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008202ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008219ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008226ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008233ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008240ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008257ZebraQ'APEL MEDICAL LLCDQY2025-01-03